Renalytix Plc Regulatory News (RENX)

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Renalytix AI plc

("RenalytixAI" or the "Company")

Early Risk Identification at Core of Innovative Kidney Care Partnership Between RenalytixAI, DaVita

First-of-its-kind program combines early risk assessment of kidney decline and comprehensive care management to help slow kidney disease progression, improve care coordination and reduce costs

NEW YORK, January 5, 2021 - Renalytix AI plc (LSE: RENX) (NASDAQ: RNLX), an artificial intelligence-enabled in vitro diagnostics company, focused on optimizing clinical management of kidney disease to drive improved patient outcomes and advance value-based care, and DaVita (NYSE: DVA) are partnering on a program aimed at slowing disease progression and improving health outcomes for the nation's estimated 37 million adults with chronic kidney disease (CKD). The program is expected to improve patient outcomes and provide meaningful cost reductions for health care providers and payors by enabling earlier intervention for patients with early-stage kidney disease (stages 1, 2 and 3) through actionable risk assessments and end-to-end care management.

The collaboration is expected to launch in three major markets this year. As the program expands, DaVita and RenalytixAI intend to pursue risk-sharing arrangements with health care providers and payors to drive kidney disease patient care innovation, cost efficiencies and improve quality of life.

"Almost 50% of people whose kidneys fail find out after it is too late, and we are on a mission to change that," said Javier Rodriguez, Chief Executive Officer for DaVita. "Our partnership with RenalytixAI could allow us to help slow disease progression for the millions of people living with kidney disease."

"This is the first clinical-grade program that delivers advanced early-stage prognosis and risk stratification, combined with actionable care management right to the primary care level where the majority of kidney disease patients are being seen," said James McCullough, RenalytixAI Chief Executive Officer. "Making fundamental change in kidney disease health economics and outcomes must begin with providing a clear, actionable understanding of disease progression risk."

The program utilizes the KidneyIntelX in vitro diagnostic platform from RenalytixAI, which uses a machine learning algorithm to assess a combination of biomarkers from a simple blood draw with features from the electronic health record to generate a patient-specific risk score. The initial version of the KidneyIntelX risk score identifies Type 2 diabetic patients with early-stage CKD as low-, intermediate- or high-risk for progressive decline in kidney function or kidney failure. The integrated program may also help reduce kidney disease misclassification, which leaves some higher-risk patients without recommended treatment. The expected outcome of the collaboration will also be used to expand indicated use claims for KidneyIntelX.

After risk stratification, program patients identified as intermediate- and high-risk will receive care management support through DaVita's integrated kidney care program, for which RenalytixAI will compensate DaVita in lieu of providing those services itself. DaVita's integrated kidney care program is comprised of a coordinated care team, practical digital health tools, award-winning patient education and other offerings. Focused on the patient experience, these services are designed to empower patients to be active in their care, delay disease progression, improve outcomes and lower costs. DaVita's team also closely collaborates with the treating nephrologist, who leads the care team, to create a seamless care experience.

For patients whose kidney disease does progress, earlier intervention can provide the patient and treating nephrologist more time to make an informed decision about the treatment option that is best for them, including pre-emptive transplantation, home dialysis or in-center dialysis. For those patients who choose to begin dialysis, the extra time increases their chance for an out-patient dialysis starts, which can help them to avoid starting dialysis with a costly hospitalization.

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The person responsible for this announcement is James McCullough, CEO.

Forward-Looking Statements

Certain statements in this press release are forward-looking statements that are subject to risks and uncertainties. These forward-looking statements include, for example, statements related to the potential benefits of the partnership between RenalytixAI and DaVita to patients, health care providers and payors. Forward-looking statements in this press release are based on management's current expectations. Various important factors could cause actual results to differ materially from these forward-looking statements, including the risks identified in the U.S. Securities and Exchange Commission filings of DaVita and RenalytixAI. Each of RenalytixAI and DaVita disclaims any obligation to update any forward-looking statement contained in this press release, except as may be otherwise required by law.

About RenalytixAI

RenalytixAI (NASDAQ:RNLX) is a developer of artificial intelligence-enabled clinical in vitro diagnostic solutions for kidney disease, one of the most common and costly chronic medical conditions globally. The Company's lead product is KidneyIntelX.com (visit www.kidneyintelx.com) which is being designed to help make significant improvements in kidney disease prognosis, transplant management, clinical care, patient stratification for drug clinical trials, and drug target discovery. For more information, visit www.renalytixai.com.

About DaVita

DaVita (NYSE: DVA) is a health care provider focused on transforming care delivery to improve quality of life for patients globally. The company is one of the largest providers of kidney care services in the U.S. and has been a leader in clinical quality and innovation for more than 20 years. Through DaVita Kidney Care, the company treats patients with chronic kidney failure and end stage kidney disease. DaVita is committed to bold, patient-centric care models, implementing the latest technologies and moving toward integrated care offerings for all. Through these efforts, DaVita has also become the largest provider of home dialysis in the country. As of September 30, 2020, DaVita served 205,300 patients at 2,809 outpatient dialysis centers in the United States. The company also operated 291 outpatient dialysis centers in nine countries worldwide. DaVita has reduced hospitalizations, improved mortality, and worked collaboratively to propel the kidney care industry to adopt an equitable and high-quality standard of care for all patients, everywhere. To learn more, visit DaVita.com/About.